Duet External Drainage and Monitoring System (EDMS)

K243676 · Medtronic Neurosurgery · JXG · Mar 10, 2025 · Neurology

Device Facts

• Record ID: K243676
• Device Name: Duet External Drainage and Monitoring System (EDMS)
• Applicant: Medtronic Neurosurgery
• Product Code: JXG · Neurology
• Decision Date: Mar 10, 2025
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 882.5550
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Duet EDMS is indicated for draining of CSF flow from the lateral ventricles or lumbar subarachnoid space in selected patients to: - Reduce intracranial pressure (ICP), e.g., pre-, intra- or postoperative. - Monitor CSF chemistry, cytology, and physiology. - Provide temporary CSF drainage in patients with infected cerebrospinal fluid shunts. Monitoring of intracranial pressure (ICP) is indicated in selected patients with: - Severe head injury - Subarachnoid hemorrhage graded III, IV, or V preoperatively - Reyes syndrome or similar encephalopathies - Hydrocephalus - Intracranial hemorrhage - Miscellaneous problems when drainage is to be used as a therapeutic maneuver. Monitoring can also be used to evaluate the status pre- and postoperatively for space-occupying lesions.

Device Story

Duet EDMS is a gravity-driven external drainage and monitoring system for cerebrospinal fluid (CSF) and intracranial pressure (ICP). It consists of a catheter (surgically inserted into ventricles or lumbar space), tubing, and a graduated drip chamber assembly. Used in clinical settings by healthcare providers to manage CSF flow and monitor pressure until patient stabilization or long-term treatment. The system uses gravity and intercerebral pressure to drain fluid into an external receptacle; drainage rate is controlled by adjusting the system height relative to the patient. Output is visual (pressure scales in cmH2O/mmHg and fluid volume in the drip chamber). Benefits include reduced ICP and ability to monitor CSF chemistry/cytology, aiding clinical decision-making for neurosurgical patients.

Clinical Evidence

Bench testing only. No clinical data provided. Testing included dimensional verification, mechanical strength (torque/load/tensile), leakage testing, flow initiation pressure, and microbial barrier efficiency (99.9% BFE). Biocompatibility testing was performed per ISO 10993-1 for prolonged external communicating devices with indirect blood path contact.

Technological Characteristics

Gravity-driven external drainage system. Components include catheter, tubing with green stripe, sliding graduated drip chamber (75 ml), and 4-way rotating pole scale. Materials evaluated for biocompatibility per ISO 10993-1. Sterilization via Ethylene Oxide. MR Conditional. No electronic energy source or software algorithms.

Indications for Use

Indicated for patients requiring CSF drainage or ICP monitoring due to severe head injury, subarachnoid hemorrhage (grade III-V), Reyes syndrome/encephalopathies, hydrocephalus, intracranial hemorrhage, or space-occupying lesions; also for patients with infected CSF shunts.

Regulatory Classification

Identification

A central nervous system fluid shunt is a device or combination of devices used to divert fluid from the brain or other part of the central nervous system to an internal delivery site or an external receptacle for the purpose of relieving elevated intracranial pressure or fluid volume (e.g., due to hydrocephalus). Components of a central nervous system shunt include catheters, valved catheters, valves, connectors, and other accessory components intended to facilitate use of the shunt or evaluation of a patient with a shunt.

Predicate Devices

• Becker External Drainage and Monitoring System (K200456)

Reference Devices

• Duet™ External Drainage and Monitoring System (K242034)

Submission Summary (Full Text)

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March 10, 2025

Image /page/0/Picture/1 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

Medtronic Neurosurgery Foram Shukla Regulatory Affairs Specialist 4620 N. Beach Street Fort Worth, Texas 76137

Re: K243676

Trade/Device Name: Duet External Drainage and Monitoring System (EDMS) Regulation Number: 21 CFR 882.5550 Regulation Name: Central Nervous System Fluid Shunt And Components Regulatory Class: Class II Product Code: JXG Dated: November 27, 2024 Received: February 6, 2025

Dear Foram Shukla:

We have reviewed your section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (the Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device"

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(https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).

Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review. the OS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.

All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rue"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-devices/device-advicecomprehensive-regulatory-assistance/unique-device-identification-system-udi-system.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

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Sincerely,

Digitally signed by Adam D. Adam D. Pierce -S Date: 2025.03.10 Pierce -S 13:56:42 -04'00'

Adam D. Pierce, Ph.D. Assistant Director DHT5A: Division of Neurosurgical, Neurointerventional, and Neurodiagnostic Devices OHT5: Office of Neurological and Physical Medicine Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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## Indications for Use

510(k) Number (if known) K243676

#### Device Name

Duet External Drainage and Monitoring System (EDMS)

Indications for Use (Describe)

The Duet EDMS is indicated for draining of CSF flow from the lateral ventricles or lumbar subarachnoid space in selected patients to:

- · Reduce intracranial pressure (ICP), e.g., pre-, intra- or postoperative.
- · Monitor CSF chemistry, cytology, and physiology.
- · Provide temporary CSF drainage in patients with infected cerebrospinal fluid shunts.

Monitoring of intracranial pressure (ICP) is indicated in selected patients with:

- · Severe head injury
- · Subarachnoid hemorrhage graded III, IV, or V preoperatively
- · Reyes syndrome or similar encephalopathies
- · Hydrocephalus
- · Intracranial hemorrhage
- · Miscellaneous problems when drainage is to be used as a therapeutic maneuver.

Monitoring can also be used to evaluate the status pre- and postoperatively for space-occupying lesions.

| Type of Use (Select one or both, as applicable) |
|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| <div> <span> <span style="font-size: 10px;">☑</span> Prescription Use (Part 21 CFR 801 Subpart D) </span> <span> <span style="font-size: 10px;">☐</span> Over-The-Counter Use (21 CFR 801 Subpart C) </span> </div> |

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### 510(k) Summary

### March 7, 2025

| I. Company: | Medtronic Neurosurgery<br>4620 N Beach Street,<br>Fort Worth, Texas 79137 USA |
|--------------------|-----------------------------------------------------------------------------------------------------------------|
| Contact: | Foram Shukla<br>Regulatory Affairs Specialist<br>[e-mail]<br>Telephone Number: 817-788-6400 |
| Alternate Contact: | Rishi Sinha<br>Senior Regulatory Affairs Director<br>[e-mail] |

II. Proprietary Trade Name: Duet™ External Drainage and Monitoring System (EDMS)

Telephone Number: 720-890-2485

III. Regulatory Class: II

#### IV. Primary Classification:

Name: Central nervous system fluid shunt and components Regulation: 21 CFR 882.5550 Classification Product Code: JXG

#### V. Identification of Legally Marketed Predicate and Reference Devices

Predicate device: Becker External Drainage and Monitoring System (K200456) Reference device: Duet™ External Drainage and Monitoring System (K242034)

#### VI. Product Description

The Medtronic Duet™ External Drainage and Monitoring System (Duet™ EDMS) is a complete draining and monitoring cerebrospinal system for externally fluid (CSF) and monitoring intracranial pressure (ICP). It can be used for both external ventricular and lumbar drainage.

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# K243676 Page 2 of 7

The Duet™ EDMS is an external drainage and monitoring system that uses gravity to drain cerebrospinal fluid (CSF) from the patient's ventricles or lumbar space to an external drainage receptacle. The drainage flow of CSF into the Duet™ EDMS is uni-directional and gravity-driven; there is no recirculation of the CSF. The Duet's catheter is surgically attached to the patient before it is attached to the drainage system. An opening is made in the patient's skull lumbar region and a catheter is inserted into patient's ventricle or the lumbar or subarachnoid space. The catheter is then attached to the drainage system. The CSF or blood is drained and monitored until the patient is stabilized, the infection successfully treated, or a long-term drainage method is implemented.

### VII. Indications for Use

The Duet™ EDMS is indicated for draining and monitoring of CSF flow from the lateral ventricles or lumbar subarachnoid space is indicated in selected patients to:

- Reduce intracranial pressure (ICP), e.g., pre-, intra- or postoperative. ●
- Monitor CSF chemistry, cytology, and physiology. .
- . Provide temporary CSF drainage in patients with infected cerebrospinal fluid shunts

Monitoring of intracranial pressure (ICP) is indicated in selected patients with:

- . Severe head injury
- . Subarachnoid hemorrhage graded III, IV, or V preoperatively
- . Reyes syndrome or similar encephalopathies
- . Hydrocephalus
- Intracranial hemorrhage .
- . Miscellaneous problems when drainage is to be used as a therapeutic maneuver.

Monitoring can also be used to evaluate the status pre- and postoperatively for space-occupying lesions.

### VIII. Summary of the Technological Characteristics

The subject device and the predicate device have the same indications for use, intended use, fundamental technology and operating principle.

### IX. Device Comparison

The tables below provide a summary of the device.

| Characteristic | Subject Device | Predicate Device |
|-------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device Name | Duet™ External Drainage and Monitoring System | Becker External Drainage and Monitoring System |
| Classification<br>Procode | JXG | GWM |
| Characteristic | Subject Device | Predicate Device |
| 510k Number | K243676 | K200456 |
| Intended Use | Draining and monitoring<br>cerebrospinal fluid (CSF) and<br>monitoring intracranial pressure<br>(ICP). | Same |
| Indications for<br>Use | The DuetTM EDMS is indicated for<br>draining and monitoring of CSF flow<br>from the lateral ventricles or lumbar<br>subarachnoid space in selected<br>patients to:<br>Reduce intracranial pressure (ICP),<br>e.g., pre-, intra- or postoperative. Monitor CSF chemistry, cytology,<br>and physiology. Provide temporary CSF drainage in<br>patients with infected CSF shunts. Monitoring of intracranial pressure<br>(ICP) is indicated in selected patients<br>with:<br>Severe head injury Subarachnoid hemorrhage graded<br>III, IV, or V preoperatively Reyes syndrome or similar<br>encephalopathies Hydrocephalus Intracranial hemorrhage Miscellaneous problems when<br>drainage is to be used as a<br>therapeutic maneuver. Monitoring can also be used to<br>evaluate the status pre- and<br>postoperatively for space-occupying<br>lesions. | Draining and monitoring of CSF flow<br>from the lateral ventricles or lumbar<br>subarachnoid space is indicated in<br>selected patients to:<br>Reduce intracranial pressure (ICP),<br>e.g., pre-, intra- or postoperative. Monitor CSF chemistry, cytology,<br>and physiology. Provide temporary CSF drainage in<br>patients with infected CSF shunts. Monitoring of intracranial pressure<br>(ICP) is indicated in selected patients<br>with:<br>Severe head injury Subarachnoid hemorrhage graded<br>III, IV, or V preoperatively Reyes syndrome or similar<br>encephalopathies Hydrocephalus Intracranial hemorrhage Miscellaneous problems when<br>drainage is to be used as a<br>therapeutic maneuver. Monitoring can also be used to<br>evaluate the status pre- and<br>postoperatively for space-occupying<br>lesions. |
| Characteristic | Subject Device | Predicate Device |
| Principle of<br>Operation | External drainage is temporary<br>drainage of cerebrospinal fluid (CSF)<br>from the lateral ventricles of the<br>brain, or the lumbar space of the<br>spine, into an external collection bag.<br>The Duet™ EDMS drains CSF by<br>using a combination of gravity and<br>intercerebral pressure. The drainage<br>rate depends on the height at which<br>the system is placed relative to the<br>patient's anatomy. | Same |
| Patient Line<br>Tubing | Visible Identification: Green stripe<br>downside of tubing to indicate<br>drainage line. | Same |
| Drip Chamber<br>Assembly | • Sliding, graduated 75 ml flow<br>chamber with drip former, tapered<br>bottom, and locking bracket.<br>• "Window" frames desired pressure<br>setting. | • Sliding, graduated 50 ml flow<br>chamber with drip former and<br>conical bottom and locking bracket.<br>• Pressure scale underlines desired<br>pressure setting. |
| Pressure Scales | • Unit of Measure: cmH2O and<br>mmHg<br>• Location: 4-way rotating pole scale<br>attached to panel<br>• Scale markings are placed onto<br>Rotating Scale Tube – one pressure<br>scale showing per $1/4$ rotation. | • Unit of Measure: cmH2O and<br>mmHg<br>• Location: Printed directly onto<br>scale<br>• Scales are side by side |
| Height<br>Adjustment Cord | Self-adjusting cord with locking<br>mechanism to adjust height of<br>drainage system. | Same |
| Device<br>Accessories | • ClearSite Laser Levels<br>• Replacement Drainage Bag. | • Replacement Laser Level<br>• Becker Quick-Attach Pole Clamp<br>with Laser Level<br>• Becker Quick-Attach Pole Clamp<br>(without Laser Level)<br>• Replacement Drainage Bag. |
| Characteristic | Subject Device | Predicate Device |
| Biocompatibility<br>- Patient contact<br>and duration | Prolonged (>24hrs - <30 days)<br>external communicating device with<br>blood path | Same |
| Shelf-life | 3 years | 2 years |
| MRI Safety<br>Information | MR Conditional | MR Unsafe |
| Sterilization<br>method | Ethylene Oxide | Same |

#### Table 1: Subject to Predicate Device Comparison - Technological Characteristics

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### X. Discussion of the Performance Testing

"Testing demonstrated the performance of the device for its intended use. The performance testing summarized in Table-2 has been conducted in support of the substantial equivalence determination for the proposed change. Results of verification and validation testing conducted on the Duet EDMS demonstrated that the subject device performed as designed, is suitable for its intended use and is substantially equivalent to the predicate device." The subject device is also identical to the reference device Duet™ External Drainage and Monitoring System (K242034).

| Test Name | Test Method Summary | Results |
|--------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------|
| Dimensional | Measure the dimensions of the scale label vertical and horizontal alignment, pressure scale lengths, patient line tubing inner diameter (ID) and length, cord length, drainage path ID (from bottom of drip chamber), and stopcock flow path diameter. | Pass |
| Drip Chamber<br>Graduations | Verify the correct readings on the drip chamber graduation. | Pass |
| Main System Stopcock<br>(MSS) Assembly<br>Torque Applied to Arm<br>of Stopcock | Record the peak torque at which the MSS assembly fails or detaches from the panel. | Pass |
| MSS Assembly Load<br>Applied to Core of<br>Stopcock Arm | Record peak load at which MSS assembly failed. | Pass |
| Test Name | Test Method Summary | Results |
| Clamp to I.V. Pole<br>Attachment Strength | Ensure secure attachment of clamp to I.V. pole. | Pass |
| Cord to I.V. Pole<br>Attachment Strength | Ensure cord and cord lock maintains secure hanging of<br>system. | Pass |
| Drip Chamber to Back<br>Panel Attachment<br>Strength | Ensure secure attachment of drip chamber/bag subassembly to<br>panel. | Pass |
| Strength of Attached<br>Junctions (Tubing to<br>Luer) | Ensure secure attachment of junctions of tubes to luer. | Pass |
| Bottom Cap to<br>Stopcock Junction<br>Torque | Ensure secure bond of stopcock/bottom cap. | Pass |
| Drip Assembly and<br>Drainage Bag Vent<br>Integrity | Ensure that drip assembly and drainage bag vent can withstand<br>appropriate fluid pressures. | Pass |
| Tensile Strength of<br>Drainage Bag Inlet Port | Evaluate the tensile strength of the drainage bag inlet port to<br>failure. | Pass |
| Drainage Bag Seal<br>Weld | Ensure there are no leaks in the drainage bag. | Pass |
| Flow Initiation Pressure | Record pressure at which flow initiates, for each drainage bag. | Pass |
| Drip Assembly Vent<br>Test (Exposure of Vent<br>to Blood Solution) | Ensure that the drip assembly vent allows drainage of blood<br>and provide CSF flow through system with minimal<br>resistance. | Pass |
| Drip Assembly Vent<br>Integrity | Test the drip assembly vent to withdraw fluid without<br>compromising its mechanical integrity. | Pass |
| Leakage of UV-Cure<br>Bonds | Record any leakage from the UV-cure bonds between the<br>patient line and drip chamber subassembly. | Pass |
| Leakage of Drainage<br>Bag | The drainage bag must withstand being inverted without<br>leaking. | Pass |
| Drip Chamber Volume | Verify fluid weight in the drip chamber. | Pass |
| Test Name | Test Method Summary | Results |
| Attachment of I.V. Pole<br>and Position of<br>Adjustable Drip<br>Chamber | Visually verify that clamping thumbscrews (and cord locks)<br>have not slipped from initial positions (using visual marks to<br>identify any slippage). | Pass |
| Leakage of UV Cure<br>Bonds | The UV-cure bonds between the patient line and drip chamber<br>subassembly should withstand air pressure without causing<br>leaks. | Pass |
| Attachment of Junctions | Junctions must be able to withstand minimum of 5-pound load<br>in the axial direction. | Pass |
| Bottom Cap to<br>Stopcock Junction<br>Torque | Test the torque of the stopcock/bottom cap bond. | Pass |
| Hydrophobic Microbial<br>Barrier Vent on the<br>Drainage Bag | The supplier for the material used as the drainage bag vents<br>conducted microbial barrier testing to demonstrate a 99.9%<br>Bacterial Filtration Efficiency (BFE). | Pass |

### Table-2: Performance Testing of Duet EDMS

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# K243676 Page 6 of 7

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# K243676 Page 7 of 7

### XI. Biocompatibility Testing

Biocompatibility assessment was conducted based on Appendix A of the FDA guidance "Use of International Standard ISO 10993-1, "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process. The Duet™ EDMS is categorized as a prolonged (>24h to 30 d) external communicating device with indirect blood path contact. The biocompatibility evaluation for the cytotoxicity, sensitization or intracutaneous reactivity, acute systemic toxicity, material-mediated pyrogenicity, subacute/subchronic toxicity, and indirect hemolysis endpoints was completed in accordance with FDA's biocompatibility guidance "Use of International Standard ISO 10993-1, "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process"".

### XII. Conclusion

The information provided in this submission demonstrates that the subject device Duet™ EDMS has the same intended use as the predicate devices. Based on the similarities of the device design, principles of operation, technological characteristics and results of the non-clinical performance testing, the subject device Duet™ EDMS is substantially equivalent to the cleared predicate device Becker External Drainage and Monitoring System (K200456).